CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Nurown MSC-NTF cells +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02017912
NCT02017912Phase 2Completed

A Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate Safety and Efficacy of Transplantation of Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors (MSC-NTF) in Patients With ALS

Brainstorm-Cell Therapeutics·interventional·Posted Dec 23, 2013·Updated Jun 6, 2024

In Brief

A Phase 2 clinical trial evaluating Nurown MSC-NTF cells and Placebo for Amyotrophic Lateral Sclerosis (ALS). Completed, enrolled 48 participants across 3 sites.

Detailed Summary

This is a multi-center, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of autologous (self) transplantation of Neurotrophic factors-secreting Mesenchymal Stromal Cells (MSC-NTF, NurOwn™) in patients with ALS . MSC-NTF cells are a novel cell-therapeutic approach which is expected to effectively deliver Neurotrophic factors, which are potent survival factors for neurons, directly to the site of damage.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 23, 2013
Enrollment StartMay 1, 2014
Primary CompletionMar 1, 2016
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.5 years ago

Interventions

Nurown MSC-NTF cellsbiological

Single autologous MSC-NTF cells treatment by combined intramuscular and intrathecal administration

Placebobiological

Excipient administration by combined intramuscular and intrathecal administration